Sterile article package



Nov. 22, 1966 N. J. PM GER STERILE ARTICLE PACKAGE 5 Sheets-Sheet lFiled March 30, 1966 INVENTOR NICHOLAS J. PILGER ATTORNEYS N ov. 22,1966 N. J. PlLGr-:R 3,286,832

STERILE ARTICLE PACKAGE Filed March 30, 1966 f 5 Sheets-Sheet 2 Y l l ll INVENIOR NICHOLAS J. PILGER BY GM] PLZMM) ATTORNEYS A Nov. 22, 1966`N. J. PILGER smal-LE ARTICLE PACKAGE Filed March 5G, 1966 5 Sheets-Sheet3 INVENTOR.

NICHOLAS J. PILGER BY 6M TQM; Malibu@ g?" ATTORNEYS United States PatentO 3,286,832 STERILE ARTICLE PACKAGE Nicholas J. Pilger, Thousand Oaks,Calif., assignor to Reynolds Metals Company, Richmond, Va., acorporation of Delaware Filed Mar. 30, 1966, Ser. No. 538,796 9 Claims.(Cl. 206-56) This invention relates to a sterile article package, andmore particularly to a package envelope for gener-al pharmaceutical useformed from air-impervious sheet material for sterile articles such assurgeons blades, hypodermic needles or the like wherein the envelope isprovided with unique opening means to prevent contact of -the sterilearticle with air-exposed portions of the envelope immediately subsequentto opening of the packglu recent years there has been increasingdevelopment of sterilized package forms as evidenced lby the patents toNashed, 3,152,694, Svirchev, 2,866,542, and Schwartz, 3,070,255, amongothers. These patents are representative also of the use of plasticfilm-aluminum foil laminate as a sterile package material, as itpossesses unique advantages in its easy handling and workability,air-impervious characteristics, ready -heat scalability, etc.

Difficulty is experienced, however, in satisfactorily opening suchpackages, commonly as by a pulling action to separate facing wrappersheets to gain access to the 'sterile contents. Such opening, however,requires that the adhesive bond between the layers of the foil besufficiently weak to permit ready yielding thereof to permit Ifullseparation of the initially sealed package plies, while strong enough toinsure sterility. A more effective means of opening packages is bytearing the package material directly, as in Lakso, 2,760,630. Thistechnique, while having the advantage of quick opening, nonetheless.permits the package contents to be in undesired proximity toair-exposed and thus contaminated external package surfaces immediatelyadjacent the edge ofthe tear, whereby medical personnel removing thepackage contents are virtually obliged to place the fingers in contactwith the uil-sterile package external surface, thereby increasing theprobability of contamination ofthe fingers or the packaged instrument,thus defeating the sterile package purpose. Y

Accordingly, it is -an important object of the present invention toprovide opening means for sterile packages wherein subsequent to openingthereof falong a line of separation, only sterile package materialremains in proximity to the access `opening to the article, whereby thedanger of germ or dirt contamination from the airexposed externa-lsurfaces off the package is prevented.

It is another object of the present invention to provide a packagehaving .a panel-and-pleat or folded collar arrangement in Iassociationwith a rip strip for effectively opening the package and exposingoutwardly facing sterile internal package surfaces, thus enhancing themaintenance of a sterile packaged contents.

It is a further object to utilize stretchablc and resilient propertiesof Ythe plastic film-metal rfoil laminate to enhance thecontamination-preventing features of the packt age.

These and other objects of the invention will become apparent from thefollowing description taken in connection with the accompanyingdrawings, in'which:

FIGURE l -is a perspective view of a .package formed in accordance withthe present invention, the internal rip strip Ibein-g shown in phantom;

FIGURE 2 is a transverse sectional view along the lines 2-2 of FIGURE l,an enclosed article being shown in phantom.

FIGURE 3 is a view similar to FIGURE 2 illustrating Fice the package yasit would appear in cross section after having been opened;

FIGURE 4 is a perspective view of a modified form of package;

FIGURE 15 is illustrative of the package of FIGURE 4 when opened and aseparated section removed;

FIGURE 6 is a sectional view along the lines 6--6 of FIGURE 4.

FIGURE 7 4is a view tagen along the line 7-7 of FIGURE 5 illustratingthe appearance of the collar on the larger section of the package afteropening;

FIGURE 8 is a plan view showing a further modified form of package, therip strip being shown in phantom;

FIGULRE 9 is a view illustrating the appearance of the FIGURE 8 packagewhen opened; and

FIGURE l0 is a sectional view of the U-collar configuration taken `onthe line 10-10 of FIGURE 8.

Referring to the drawings, in the several forms of the invention, theenvelope 1-4 is preferably formed of a lmsfoillaminate comprisingaluminum foil 10 as the external surface and vapor barrier while areadily sealable adhesive film 12 such as polyethylene, corn-prises theinternal sterile surface of the p-ackage envelope 14.

In the package of FIGURES l to 3, the envelope 14 is folded from `asingle sheet of film-foil laminate and is provided with Ialongitudinally extending seam 16 (FIGURE 2) and a pair of transverse endseals 18, 18. One wall o'f the envelope includes a longitudinallypleated collar-like panel portion Z8 having a pair of outwardlyextending portions 22 which underlie and respectively reversely fold andmerge into a closure panel 24. rip strip 26 is bonded internally of theenvelope to the underside of panel 24 and extends the entire lengththereof, a short piece 30 thereof extending outwardly from the envelopeat one or both ends. Enclosed within the envelope as indicated in dashedlines tat 32 are sterile instruments such as ampules, surgeons knife orblade, hypodermic needles, etc.

The package 14 is sterilized in conventional fashion during orsubsequent to formation thereof, whereby the article 32 within ftheenvelope Eas well as all internal surfaces of the envelope will begerm-free. In the ordinary handling of the package, of course, theexternal package surface is exposed to normal Iatmospheric and contactcontamination.

In opening, grasping and pulling rip strip 30 tears panel 24 along aline defined by strip 30, thus separating panel 24 into two sections,each respectively connected to the underlying inturned portions 2v2. Byvirtue ofthe limited resilience o'f the plastic film 22, the upwardstress of the tearing 'action in pulling the rip strip 26 along thelength of panel 24 will slightly stretch the internal sterile surface'12 while the foil edge areas Y adjacent the line of separation at 34tend to bend upwardly and outwardly. As the pulling forces terminate,

the effective elastic memory of plastic film 12 aids the Y panel edges34 in curling outwardly from the line of separation, as clearlyindicated in somewhat exaggerated yform in FIGURE 3.

By virtue thereof, it will be seen that the internal sterile envelopesurface of film 12 is disposed immediately adjacent either side ofaccess opening 36, and extends laterally therefrom along substantiallytheY entire length of the package, whereby upon the user inserting hisfingers into the envelope to extract the contents 32 thereof, thefingers will contact only sterilized internal surfaces 12 and will notbe in proximity to the air-exposed and contaminated external surface 10of the package. Thus the contents 32, such as surgical instruments,hypodermic needles, etc., maybe removed from the package without anydirect contact with the unsterile external surface 10.

The modified package 40 shown in FIGURES 4-7 is similar to that ofFIGURES l-3, wherein, however, the pleated collar arrangement isdisposed transversely of the envelope in substantially girdling relationthereto, rather than longitudinally thereof. As before, the package 40is conveniently formed from a single sheet of film-foil laminate toprovide an outer foil surface 10 and an inner film surface 12. Thepackage includes a longitudinally extending side seam 42 and end seams44, 44. As seen in FIGURE 6, the package is pleated in the mannersimilar to FIGURE 2, the pleat portions 48 and associated panel 50,however, extending peripherally of the package intermediate the endsthereof. Arip strip 52 underlies panel 50, and one or both ends thereofextend through the side seam 42 so as to be readily grasped when it isdesired to open the package. While, as illustrated, the rip strip 52loopsl about the package, the same may extend only the width of one sideof the flattened oblong envelope, if desired.

In the package 40 as shown, when the rip strip 52 is pulled by the user,the overlying portion of the film-foil laminate panel 50 bonded theretowill be torn away, and the panel substantially completely separatedalong the line of the rip strip. While the side seam 42 will notusuallyk be separated by the strip 52, the same will nonetheless becapable of being readily torn by the user if desired.

In any event, -upon completion of the tearing operation by rip strip 52,and as before, stretching of the sterile film laminate will enhanceself-curling of the envelope edges 54 on either side of the rip strip,whereby the same will tend to curl lbackwardly as seenin FIG- URES `5and 7 to upwardly expose the sterile inner envelope surface. Similarcurling will, of course, occur on the shorter portion of the package(not shown). Thus, as before, the article or articles 32 within thepackage will be readily accessible and may be grasped Without the handof the user or the articles themselvesy coming into contact with anynon-sterile external surfaces of the package.

In the form of the invention shown in FIGURES 8-10, the package 60 asbefore is provided with a transverse collar-like pleat formation 62which is substantially parallel to the end seams 64, wherein, however,Vthe pleat configuration partakes of "a telescoped double-Uconfiguration as clearly seen in FIGURE 10. Also as before, the tearstrip 66 projects through the side seam 68 of the envelope withoutrequiring any notching or cutting thereof, the tear strip being merelysealed between the facing envelope plies.

The double-U fold providing the novel collar 62 V.of FIGURES 8-10includes features which facilitate use thereof as a temporary reclosureshould all package contents not be initially removed from the envelopeupon opening.

More particularly, asy seen in the enlarged view of FIGURE 10 of thedrawings, the envelope wall is outwardly reversely folded and then againoutwardly reversely folded to form an outer U-portion 70. The tear stripis disposed adjacent the outermost ply or panel 71 of U-portion 70. Theother edge of panel 71 is reversely folded inwardly at 73 to define asecond, smaller lU- portion 72 telescoped within the larger U-portion70, the other edge 74 of U-portion 72 merging back into the Wall panel.Thus it will be seen that when the rip strip 66 separates panel 71 insimilar manner as before, the foil torn thereabove and theresultantexposed surfaces following curl-back will be the internalsterile surfaces of the U-folds, as clearly seen in FIGURE 9. Note,however, that subsequent to tearing the package contents are not visiblefor immediate grasp inasmuch as the double-U fold still provides atelescoping closure-therearound. Upon manual separation of the oppositeends of the package to open the telescoping folded portions thereof asseen in FIGURE 9, the article 32 may be readily grasped, and it will beseen that as before, the

`article 32 is free from possible non-sterile contamination ia portionof said envelope defining a panel fhaving open-` ing means associatedvtherewith vfor separating said panel along a line to gain access tosaid article,

a-nd means cooperating with said opening means tend-- ing Ito curl thepanel areas |adjacent said separa-tion line upwardly :and outwardlythere-imm no upwardly expose said sterile internal sunfaoe rthereat oneither side of said sepanation line, Y whereby contact of the packagedantziole with thek rel-a- -t-vely runsterile package external surface isprevented during withdrawal of said article through said sep-v aratedpanel.

2. The package of claim 1 wherein said opening means comprises a ripstrip disposed in underlying bonded relarton to said panel internalsulnface, and having a strip portion projecting externallly of saidpackage for grasping. ,n

3. The package .of claim 2 wherein said package matef rial is metallicfoil, and said curl means includes a plastic film bon-ded to said foilon the inside surface ofV said panel, said plastic film being yieldable.to package opening forces, and having sufficient resilience` that`upward tearing force of said rip strip slightly stretches duringrupture of said panel, whereby upon cessation of .tearing forces, slightcontraction of Athe plastic aids in outward curling of said panel areas.

4.` The` package of claim 2 wherein `said pane-l oon- Sttutes -a portionof a pleated oollar of said envelope,

said col'lar comprising said panel and la pleat pontionV extendinginwardly of and Iunder'said panel from eachY edge thereof, each `pleat.pomtion terminating in a reversely` extending yfotld with -tlheremainder of said envelope,

whereby upon opening of said envelope by separation of said panel, theupwardly facing internal sterile` surfaces o-f said ple-at portions areexposed, the gap p therebetween providing access to said packagedarticle. 5. The package of claim 4 wherein said envelope is of agenerally attened, oblong configuration and saidtcol-V -lar extendslongitudinally `along one side thereof.;

6. 'Ihe package of claiLm4 wherein said envelope-is of 4a Vgenerallyflattened oblong configuration, and said col-Y ar extends transverselytherearound in substantially girdlin-g relation mhereto.

7. The package of claim 2 wherein said panel constitutes a portion of adouble U-oollan Y said collar including an outwardly reversely :foldedportion of saidenvelope `merging atk an outward reverse fold with-oneedge of said panel, Itogether defining an outer U-ponti'onj? rthe panelother edge menging at 'an inward reverse fold with an inner U-pontionwhich connects with che remainder of Isaid envelope,` with said inner U-portion being telescoped within said outer 'U-portion,

whereby separation of said panel 'along said line exposes :the sterileinternal surfaces of said U portions, which may be outwardly ytelescopedto separate the same Ito gain access fbo lthe packaged article.

8. The package of claim 2 wherein said envelope com-` 5 prises a singleolded sheet having a sealed margin, and said nip strip extends throughsaid seaded margin.

9. The package of claim 4 wherein said package mate- Tial is .metallli'cfoil, and Vsaid curl means includes a plastic dilm bonded to said foilon the inside surface of said panel, said plastic lm being yieldabde to'package Opening forces, and lhavi-ng suicient resilience that upward4tearing or of said 'ri-p strip slightly stretches said lm duringrupture of said panel, whereby upon Icessati-on of tearing forces,slight contraction of the plastic .aids in outward curling of said panelareas.

No references cited.

THERON E. CONDON, Primary Examiner.

J. M. CASKIE, Assistant Examiner.

1. A STERILE ARTICLE PACKAGE COMPRISING AN ENVELOPE OF AIR-IMPERVIOUS MATERIAL SURROUNDING AND ENCLOSING THE ARTICLE, SAID ENVELOPE HVING A STERILE INTERNAL SURFACE, A PORTION OF SAID ENVELOPE DEFINING A PANEL HAVING OPENING MEANS ASSOCIATED THEREWITH FOR SEPARATING SAID PANEL ALONG A LINE TO GAIN ACCESS TO SAID ARTICLE, AND MEANS COOPERATING WITH SAID OPENING MEANS TENDING TO CURL THE PANEL AREAS ADJACENT SAID SEPARATION LINE UPWARDLY AND OUTWARDLY THEREFROM TO UPWARDLY EXPOSE SAID STERILE INTERNAL SURFACE THEREAT ON EITHER SIDE OF SAID SEPARATION LINE, WHREBY CONTACT OF THE PACKAGED ARTICLE WITH THE RELATIVELY UNSTERILE PACKAGE EXTERNAL SURFACE IS PREVENTED DURING WITHDRAWAL OF SAID ARTICLE THROUGH SAID SEPARATED PANEL. 